Effect of Enhanced Recovery After Surgery(ERAS) After Liver Resection for Primary Liver Cancer

Not Applicable

• Conditions: Carcinoma, Hepatocellular
• Interventions: Procedure: Enhanced Recovery After Surgery

• Registration Number: NCT02644603
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

The purpose of this study is to evaluate Enhanced Recovery After Surgery(ERAS) protocol versus conventional treatment on patients who underwent liver resection for hepatocellular carcinoma(HCC).

Detailed Description

212 patients are randomly recruited from inpatients of Shanghai Zhongshan Hospital, Eastern Hepatobiliary Surgery Hospital, RenJi Hospital, Anhui Provincial Hospital, Subei People's Hospital of Jiangsu Province and Affiliated Tumor Hospital of Nantong University from February 2016 to July 2016. Randomly assigned about half of the patients to receive Enhanced Recovery After Surgery(ERAS) protocol and the other half to receive conventional treatment. Evaluate the safety and efficacy of the ERAS protocol.

Study Timeline

• Study First Submitted: 2015-12-15
• Study First Submitted QC: 2015-12-30
• Study First Posted: 2016-01-01
• Study Start: 2016-02
• Primary Completion: 2016-12
• Status Verified: 2017-06
• Study Completion: 2017-06
• Last Update Submitted: 2017-06-24
• Last Update Posted: 2017-06-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

• Diagnosed with HCC with indications for surgery
• Without any surgical contraindications
• Under went open liver resection
• Operation ranges less than 4 hepatic segments
• Informed consent

Exclusion Criteria

• Not suitable for surgery
• Benign lesions or other lesions proved by pathology
• Surgical procedure changed during operation or combined evisceration
• Refused to participate or drop out

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Recovery After Surgery	Enhanced Recovery After Surgery	Patients underwent ERAS protocol

Primary Outcome Measures

Name	Time	Method
Treatment related complications	Up to 1 month since operation	Number of adverse events that are related to treatment of each patients, and hospital readmission

Secondary Outcome Measures

Name	Time	Method
Total hospitalization costs	From the day a patient be hospitalized to the day discharged, up to 1 month.	Total hospitalization costs (RMB yuan).
Preoperative and postoperative body weight	One day before operation, and the day patient discharged, up to 1 month.	Patient's body weight in kg.
PRE-Albumin (PRE-A)	Day before operation and day 1/3/5 after operation.	PRE-A in g/L
International Normalized Ratio (INR)	Day before operation and day 1/3/5 after operation.	INR in seconds.
Albumin (ALB)	Day before operation and day 1/3/5 after operation.	ALB in g/L.
Blood Urea Nitrogen (BUN)	Day before operation and day 1/3/5 after operation.	BUN in mmol/L
Length of stay in hospital	From the day a patient be hospitalized to the day discharged, up to 1 month.	Length of stay in hospital (days)
Aspartate Transaminase (AST)	Day before operation and day 1/3/5 after operation.	AST in U/L
Hemoglobin (Hb) test Hb/ALB/PRE-A(g/L),	Day before operation and day 1/3/5 after operation.	Hb in g/L.
Platelet (PLT)	Day before operation and day 1/3/5 after operation.	PLT in 10\^9/L
Serum complement	Day before operation and day 1/3/5 after operation.	C3 and C4 in mg/dl
Blood Creatinine (sCr)	Day before operation and day 1/3/5 after operation.	sCr in umol/L
Alanine Transferase (ALT)	Day before operation and day 1/3/5 after operation.	ALT in U/L
Interleukin-6 (IL-6)	Day before operation and day 1/3/5 after operation.	IL-6 in (pg/ml)
Interferon (IFN-γ)	Day before operation and day 1/3/5 after operation.	IFN-γin pg/ml.
Tumor necrosis factor-α (TNF-α)	Day before operation and day 1/3/5 after operation.	TNF-αin pg/ml

Trial Locations

Locations (1)

Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China